The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health(2)

NCT01836887 | Completed

• 2 other identifiers: TSB101118 (2)Technology Strategy Board
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product.

Conditions

Healthy Men and Women

Keywords

Polyphenol; Fruit; Metabolic; Healthy

Outcome Measures

Primary Outcomes (1)

• Metabolic health

  Postprandial metabolic response

  Postprandial response (2hrs)

Study Arms (3)

Intervention 1

PLACEBO COMPARATOR

Very low polyphenol fruit based drink (control)

Dietary Supplement: Very low polyphenol fruit based drink (control)

Intervention 2

ACTIVE COMPARATOR

Polyphenol-enriched fruit-based drink - low

Dietary Supplement: Polyphenol-enriched fruit-based drink - low

Invervention 3

ACTIVE COMPARATOR

Polyphenol-enriched fruit-based drink - high

Dietary Supplement: Polyphenol-enriched fruit-based drink - high

Interventions

Very low polyphenol fruit based drink (control) DIETARY_SUPPLEMENT

Intervention 1

Polyphenol-enriched fruit-based drink - low DIETARY_SUPPLEMENT

Intervention 2

Polyphenol-enriched fruit-based drink - high DIETARY_SUPPLEMENT

Invervention 3

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand the information sheet and comply with all the trial procedures
• Having given written consent to take part in the study prior to participation.
• Body mass index (BMI): 18.0 - 35 kg/m².

You may not qualify if:

• Those diagnosed with Phenylketonuria (PKU)
• Those with known or suspected food intolerances, allergies or hypersensitivity
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study
• Women who are breast feeding
• Participation in another clinical trial
• Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months
• Those with Full Blood Counts and Liver Function test results outside of the normal range
• Pre-menopausal women due to the potential influence of cyclical changes in reproductive hormones on insulin sensitivity
• Current smokers, or reported giving up smoking within the last 6 months
• History of substance abuse or alcoholism
• Reported history of CVD, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function
• Unwilling to restrict consumption of specified high polyphenol foods for 24 h before the study
• Weight loss \>3kg in preceding 2 months and body mass index \<18 or \>35 kg/m²
• Blood pressure ≥160/100 mmHg
• Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L

Sponsors & Collaborators

• King's College London: lead
• Lucozade Ribena Suntory: collaborator

Study Sites (1)

Diabetes & Nutritional Sciences Division, School of Medicine, King's College London

London, SE1 9NH, United Kingdom

Location

Related Links

• Thesis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 22, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

GB (1)